Diabetes Prevention Program Feasibility Study of Breastfeeding

The purpose of this study is to learn about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Overweight and Obesity
• Intervention / Treatment: Behavioral: Diabetes Prevention Program; Behavioral: Breastfeeding Education; Behavioral: Usual Care

Detailed Description

This pilot randomized controlled trial seeks to determine the feasibility and efficacy of a combined breastfeeding, DPP-based program in a cohort of overweight/obese women to be followed during pregnancy through 6 months postpartum. The pilot trial will have three study arms: DPP + breastfeeding (Tx1), DPP only (Tx2), and usual care (Tx3). Specific aims are: 1) To test the efficacy of Tx1 to improve 6-month postpartum weight loss among women with a BMI >/= 25. 2) To test the efficacy of Tx1 to improve 6-month postpartum mean blood glucose (HbA1c) and mean arterial blood pressure among women with a BMI >/= 25. 3) To test the efficacy of Tx1 to increase any breastfeeding through 6 months postpartum among women with a BMI >/= 25.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lakin, Kansas, United States, 67860
      • Kearny County Hospital
    • Wichita, Kansas, United States, 67218
      • Via Christi Maternal Fetal Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant, 1st trimester or early 2nd trimester
• Interested in breastfeeding
• BMI >/= 25 and <35
• Able to read and understand English
• Able to learn and use Facebook
• Able to learn and use Skype, FaceTime or Zoom for virtual meetings
• Must have a cell phone

Exclusion Criteria:

• Pregnancy complications that require emergency care
• Thyroid disease
• Multiple gestation
• Substance abuse within last 3 years
• ART (Assisted Reproductive Technology) pregnancy
• Current smoker
• Prior bariatric surgery
• In weight-loss program within 3 months of conception
• BMI >/= 35
• Unable to attend intervention / follow-up visits
• Unwilling to self-monitor data collection
• Unable to complete intervention
• Presence of any condition that limits walking
• Presence of any condition that limits following diet recommendations
• Pregnancies complicated with fetuses diagnosed with lethal malformations / conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care; Patients randomized to Tx1 will receive education in both the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions (core curriculum), one 2-hour breastfeeding session, and participation in a professional peer support group. The 2-hour breastfeeding session is pre-recorded into four (4) 30-minute sessions and archived on a secure, private Facebook group. Participants will have access to all four breastfeeding sessions by week 24 of pregnancy and they need to complete all sessions by week 30 of pregnancy. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support (at day 3, day 10, week 3 and week 6), followed by 6 DPP sessions (post-core curriculum).	Behavioral: Diabetes Prevention Program; Phase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy.; Behavioral: Breastfeeding Education; Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.; Behavioral: Usual Care; Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Active Comparator: Intervention 2 (Tx2) - DPP Only + Usual Care; Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions (core curriculum). At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions (post-core curriculum).	Behavioral: Diabetes Prevention Program; Phase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy.; Behavioral: Usual Care; Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Placebo Comparator: Intervention 3 (Tx3) - Usual Care Only; Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.	Behavioral: Usual Care; Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms.	At baseline and at delivery through 6 months postpartum
Change in HbA1c	The study team will measure mean blood glucose at baseline and at 6 months postpartum.	At baseline and at 6 months postpartum
Change in Arterial Blood Pressure	The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum.	At baseline, at delivery, and at 6 months postpartum
Duration of Breastfeeding	The study team will measure duration of breastfeeding from delivery through 6 months postpartum.	At delivery through 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)	To assess levels of self-efficacy. Survey consists of 14 items. All items are preceded by the phrase "I can always" and are anchored with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. All items are presented positively, and scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.	At baseline and at 6 months postpartum
Kaiser Physical Activity Survey (KPAS, Weighted Total)	To assess multiple domains of physical activity and total physical activity before and after pregnancy. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5 (scores ranged from 1 for "never" or "none" to 5 for "always" or "more than once a week" in each physical activity domain). Higher scores indicate greater overall activity levels. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index*0.25 + occupational index*0.25 + active living index*0.25 + sports/exercise index*0.25) * 4. The total activity score has a potential range of 4 - 20 with a mean of 10.42 (SD=2.00). A higher total activity score indicates a greater activity level.	At baseline and at 6 months postpartum
Fruit & Vegetable Intake Screener (EATS)	To assess intake of fruits and vegetables before and after pregnancy. Survey consists of 10 items; with portion-size questions. Each question has two parts, asking over the last month how often a particular item was consumed (i.e.: never, 1-3x/mo, 1-2x/wk, etc.) and how much was usually consumed (i.e.: <3/4cup, 3/4 to 1 1/4 cup, >2 cups, etc.). Frequency is scored from 0.0-5.0, with 0 meaning never, and 5.0 meaning 5 or more servings per day.	At baseline and at 6 months postpartum
Edinburgh Postnatal Depression Scale (EPDS)	To assess levels of depression during the postpartum period. Survey consists of 10 items. Questions 1, 2, & 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3, 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score is 30. A score of 10 or higher generally indicates a potential need for further assessment regarding possible depression, while scores above 12 or 13 may suggest a higher likelihood of depression requiring medical attention. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up.	Postpartum

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Ascension Via Christi Hospitals Wichita, Inc.; Kearny County Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Actual): May 7, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: breastfeeding; prediabetes; diabetes prevention program
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: KU-VC1752; 1K01DK113048-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No